Spectral Markers in Aspirin Chemoprevention of Colonic Neoplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Fractal Dimension or FRAC) From Baseline to 3 Months.
研究概览
简要总结
This randomized phase II trial is studying how well aspirin works in preventing colorectal cancer in patients at increased risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer.
详细描述
PRIMARY OBJECTIVE:
I. Determine whether acetylsalicylic acid (aspirin) will alter spectral markers (i.e., spectral slope and fractal dimension) in distal colonic mucosa of patients who are at increased risk for the development or recurrence of colorectal cancer.
SECONDARY OBJECTIVES:
I. Assess the effect of this drug on colonic epithelial apoptosis and cell proliferation in these patients.
II. Assess the effect of this drug on rectal prostaglandin levels in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral acetylsalicylic acid (aspirin) once daily.
干预措施: acetylsalicylic acid (Drug)
Arm I
Patients receive oral acetylsalicylic acid (aspirin) once daily.
干预措施: laboratory biomarker analysis (Other)
Arm II
Patients receive oral placebo once daily.
干预措施: placebo (Drug)
Arm II
Patients receive oral placebo once daily.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Fractal Dimension or FRAC) From Baseline to 3 Months.
时间窗: 3 months from baseline colonoscopy to end of intervention.
Spectral marker assessment was performed via LEBS analysis (low-coherence enhanced backscattering spectroscopy) on the uninvolved mucosal biopsies of subjects taken at baseline and after 3 months of treatment with either aspirin or placebo. FRAC characterizes the spatial autocorrelation function of mass density distribution in tissue. SPEC and FRAC provide a measure of the fundamental characteristics of the tissue nanoscale architecture
Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Spectral Slope or SPEC) From Baseline to 3 Months.
时间窗: 3 months from baseline colonoscopy to end of intervention.
Spectral marker assessment was performed via LEBS analysis (low-coherence enhanced backscattering spectroscopy) on the uninvolved mucosal biopsies of subjects taken at baseline and after 3 months of treatment with either aspirin or placebo. SPEC characterizes the size distribution of macromolecular complexes and other intracellular structures, with a decrease of the spectral slope implying a shift of the size distribution of intracellular structures toward smaller sizes. Spectral markers SPEC and FRAC provide a measure of the fundamental characteristics of the tissue nanoscale architecture.
次要结局
- Changes in Colonic Cell Proliferation as Measured by Immunohistochemical Detection of Ki67(3 months from baseline colonoscopy to end of intervention.)
- Rectal Prostaglandin Levels as Measured by ELISA(3 months from baseline colonoscopy to end of intervention.)
- Colonic Epithelial Apoptosis as Measured by Immunohistochemical Detection of Cleaved Caspase 3(3 months from baseline colonoscopy to end of intervention.)